Adult Dosing
Primary hypercholesterolemia
Fenofibrate, Lofibra
- Start dose: 200 mg PO qd
- Max: 200 mg/day
- Start 67 mg PO qd and if needed increase q4-8wk in geriatrics
Note: Administer with meal
Antara
- Start dose: 130 mg PO qd
- Max: 130 mg/day
- Start 43 mg PO qd and if needed increase q4-8wk in geriatrics
Mixed dyslipidemia
Fenofibrate, Lofibra
- Start: 200 mg PO qd
- Max: 200 mg/day
- Start 67 mg PO qd and if needed increase q4-8wk in geriatrics
Note: Administer with meal
Antara
- Start dose: 130 mg PO qd
- Max: 130 mg/day
- Start 43 mg PO qd and if needed increase q4-8wk in geriatrics
Hypertriglyceridemia
Fenofibrate, Lofibra
- 67-200 mg PO qd
- Start 67-200 mg PO qd and if needed increase q4-8wk
- Max: 200 mg/day
- Start 67 mg PO qd in geriatrics
Note: Administer with meal
Antara
- 43-130 mg PO qd
- Start 43-130 mg PO qd and if needed increase q4-8wk
- Max: 130 mg/day
- Start 43 mg PO qd in geriatrics
Pediatric Dosing
- Safety and effectiveness in pediatrics have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
- Fenofibrate, Lofibra
- <50 mL/min: Contraindicated
- 50-90 mL/min: Start 67 mg PO qd
- Antara
- <50 mL/min: Contraindicated
- 50-90 mL/min: Start 43 mg PO qd
Hepatic Dose Adjustment
- Hepatic impairment: Contraindicated
See Supplemental Patient Information
- Doses equivalent to 134-200 mg are associated with increasing serum transaminase levels. Increase in transaminase levels are dose dependent. Hepatocellular, chronic active and cholestatic hepatitis have occurred after exposure to therapy for weeks to several years. Rare occasions of cirrhosis have been reported in association with chronic active hepatitis. Monitor liver function regularly, including serum ALT (SGPT). Perform such tests for the duration of therapy. Discontinue therapy if enzyme levels >3x the normal limit persist
- Conduct gallbladder studies if cholelithiasis is suspected. Discontinue therapy on presence of gallstones
- Exercise caution when anticoagulants are administered in conjunction with fenofibrate capsules. Reduce the dosage of the anti-coagulant for maintaining the prothrombin time/INR at the desired level for prevention of bleeding complications. Frequently monitor prothrombin time/INR until it is determined that the prothrombin time/INR has stabilized
- Rare occasions of myositis, myopathy, or rhabdomyolysis have occurred. Medically evaluate patients complaining of muscle pain, tenderness, or weakness for myopathy and serum creatine kinase levels. On suspection or diagnosis of myopathy/myositis, cease therapy with fenofibrate capsules
- Effect on coronary heart disease morbidity and mortality and non-cardiovascular mortality have not been established
- Discontinue medications, or if feasible change them prior to consideration of triglyceride-lowering medications, as exacerbation of hypertriglyceridemia has occurred
- Periodically determine serum lipids during initial therapy for establishing the lowest effective dose. Withdraw therapy in patients having inadequate response after 2 months of therapy with the maximum recommended dose of 200 mg/day
- Pancreatitis has occurred in association with failure of efficacy in patients with severe hypertriglyceridemia or a secondary phenomenon mediated through biliary tract stone or sludge formation with obstruction of the common bile duct
- Rare occasions of acute hypersensitivity reactions including severe skin rashes requiring patient hospitalization has occurred
- Hematologic changes have occurred following initiation of fenofibrate therapy. Periodically determine blood counts during the first 12 months of therapy with fenofibrate
- Assess CPK levels in patients reporting unexplained muscle pain, tenderness or weakness, and discontinue fenofibrate therapy on marked elevated CPK levels or diagnoses of myopathy
Cautions: Use cautiously in
- Renal impairment
- Concurrent nephrotoxic agents
- Geriatrics
Supplemental Patient Information
- Advise patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever
Antara, Lofibra interacts with :
Pregnancy Category:C
Breastfeeding: Relevant published information on the use of fenofibrate during breastfeeding is unavailable. Prefer an alternate drug especially while nursing a newborn or preterm infant. (This information is available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 9 March 2011). Avoid using this drug in nursing mothers. Manufacturer advises to make a decision for discontinuing nursing or to discontinue the drug.
Pricing data from www.DrugStore.com in U.S.A.
- Lofibra 200 MG CAPS [Bottle] (GATE)
30 mg = $105.59
90 mg = $292.56 - Antara 130 MG CAPS [Bottle] (LUPIN PHARMACEUTICALS)
30 mg = $182
90 mg = $505.97 - Lofibra 67 MG CAPS [Bottle] (GATE)
30 mg = $43.99
90 mg = $109.97 - Lofibra 134 MG CAPS [Bottle] (GATE)
30 mg = $72.59
90 mg = $193.56
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Antara 130 MG Oral Capsule
Ingredient(s): Fenofibrate
Imprint: 130;ANTARA;OSCIENT
Color(s): Green, White
Shape: Capsule
Size (mm): 18.00
Score: 1
Inactive Ingredient(s): sugar spheres / hypromellose / sodium lauryl sulfate / dimethicone / simethicone / talc
Drug Label Author:
Oscient Pharmaceuticals Corporation
DEA Schedule:
Non-Scheduled
Drug Name: Antara 43 MG Oral Capsule
Ingredient(s): Fenofibrate
Imprint: 43;ANTARA
Color(s): Green, White
Shape: Capsule
Size (mm): 14.00
Score: 1
Inactive Ingredient(s): sugar spheres / hypromellose / sodium lauryl sulfate / dimethicone / simethicone / talc
Drug Label Author:
Oscient Pharmaceuticals Corporation
DEA Schedule:
Non-Scheduled
